Principal Medical Writer

Job Title: Principal Medical Writer Job Location: Durham, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Overview We are seeking an experienced Principal Medical Writer to lead the development of high-quality clinical and regulatory documents supporting global regulatory submissions. This role plays a critical part in ensuring that documents such as Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and Module II summaries that are scientifically accurate, consistent, and aligned with program objectives and global regulatory requirements. The successful candidate will act as a lead writer for key summary documents , providing strategic guidance to cross-functional teams while overseeing medical writing activities across multiple compounds. This position reports to the Director of Medical Writing (or above). Key Responsibilities Lead the development of high-quality clinical and regulatory documents (e.g., Investigator’s Brochures, Clinical Study Reports, clinical summaries, and marketing authorization submissions) in compliance with global regulatory guidelines (ICH, FDA, EMA) and internal standards Serve as the lead writer for key summary documents, overseeing medical writing activities across multiple compounds or programs Provide strategic guidance to cross-functional teams on document content, messaging, and regulatory positioning to ensure alignment with program goals Manage medical writing projects, including planning, timelines, resource coordination, and delivery to ensure milestones and submission deadlines are met Collaborate with cross-functional stakeholders (Clinical, Regulatory Affairs, Biostatistics, Safety, etc.) to gather, interpret, and accurately present clinical data Mentor and support other medical writers, ensuring high-quality, scientifically sound, and consistent deliverables across projects Review and edit project-related documents to ensure accuracy, clarity, consistency, and compliance with templates and style guides Attend project and team meetings to provide expert input on document development, study data interpretation, and process improvements Contribute to and lead process improvement initiatives to enhance efficiency, quality, and consistency in document preparation Develop, maintain, and refine standard operating procedures (SOPs), templates, and best practices for medical writing Stay current with evolving global regulatory requirements,...

Summary and match are AI-generated; verify details on the original posting.

Listed via Himalayas. All sources